INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Trial Readiness (R21 Clinical Trial Not Allowed)

The National Institutes of Health (NIH) has launched a comprehensive investigation project named "INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE" (shortly known as INCLUDE). The primary objective of this project is to enhance the well-being and quality of life of those living with Down Syndrome.

The INCLUDE project is now inviting researchers to apply for funding in support of clinical projects that lay the groundwork for eventual clinical trials related to Down Syndrome. This effort is aimed at tackling the urgent need to prepare for these trials and encourage the effective progress of potential treatments or diagnostic methods towards clinical trials tailored for Down Syndrome and its associated conditions.

To improve the success rate of these trials, this funding also encourages the development and examination of indicators (biomarkers) and ways to assess clinical outcomes. Besides, the funding will also support the creation and evaluation of innovative trial methods and strategies to attract participants.

Furthermore, NIH is interested in projects that can clarify the manifestation and progression of conditions that co-occur with Down Syndrome. Such critical information will help design future clinical trials more effectively, ensuring they address the needs of individuals with Down Syndrome.